Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC...
FDA Recall #D-0795-2020 — Class II — December 20, 2019
Product Description
Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling Firm
Denton Pharma, Inc. — North Blenheim, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
467 bottles
Distribution
Nationwide
Code Information
a). N106851901, Exp. 11/30/2021 N106851902, Exp. 10/31/2021 b). C106851901, Exp. 11/30/2021 C106851902 Exp. 10/31/2021 C106851903 Exp. 02/28/2022 C106851904 Exp. 11/30/2021 C106851905 Exp. 05/31/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated